Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Sitaxentan
Drug ID BADD_D02031
Description Sitaxentan was marketed under the trade name Thelin for the treatment of pulmonary arterial hypertension (PAH) by Encysive Pharmaceuticals until Pfizer purchased Encysive in February 2008. In 2010, Pfizer voluntarily removed sitaxentan from the market over concerns of hepatotoxicity.
Indications and Usage Investigated for use/treatment in pulmonary hypertension, connective tissue diseases, hypertension, and congestive heart failure.
Marketing Status approved; investigational; withdrawn
ATC Code C02KX03
DrugBank ID DB06268
KEGG ID D07171
MeSH ID C106276
PubChem ID 216235
TTD Drug ID D0T1RG
NDC Product Code Not Available
UNII J9QH779MEM
Synonyms sitaxsentan | N-(4-chloro-3-methyl-5-isoxazolyl)-2-(3,4-(methylenedioxy)-6-methyl)phenylacetyl-3-thiophenesulfonamide | N-(4-chloro-3-methyl-5-isoxazolyl)-2-((4,5-(methylenedioxy)-O-toly)acetyl)-3-thiophenesulfonamide | TBC-11251 | TBC 11251 | TBC11251
Chemical Information
Molecular Formula C18H15ClN2O6S2
CAS Registry Number 184036-34-8
SMILES CC1=CC2=C(C=C1CC(=O)C3=C(C=CS3)S(=O)(=O)NC4=C(C(=NO4)C)Cl)OCO2
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice.
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Hypocalcaemia14.04.01.004--
Hypoglycaemia05.06.03.001; 14.06.03.001--
Hypotension24.06.03.002--
Hypoxia22.02.02.003--
Immune system disorder10.02.01.001---
Increased appetite08.01.09.027; 14.03.01.003---
Infection11.01.08.002---
Injection site dermatitis08.02.03.041; 12.07.03.041; 23.03.04.033---
Insomnia17.15.03.002; 19.02.01.002--
International normalised ratio increased13.01.02.008--
Intertrigo23.03.04.028---
Jaundice01.06.04.004; 09.01.01.004; 23.03.03.030---
Joint stiffness15.01.02.003---
Lacrimation increased06.08.02.004--
Lactic acidosis14.01.01.002---
Leukopenia01.02.02.001---
Ligament sprain12.01.07.008; 15.07.02.004---
Liver function test abnormal13.03.04.030---
Localised infection11.01.08.006---
Lower respiratory tract infection11.01.09.002; 22.07.01.002---
Lymphoma01.12.01.001; 16.20.01.001---
Malaise08.01.01.003--
Memory impairment17.03.02.003; 19.20.01.003--
Menopausal symptoms21.02.02.002---
Mental disability26.01.01.001---
Migraine17.14.02.001; 24.03.05.003---
Mouth haemorrhage07.05.02.001; 24.07.02.014--
Muscle atrophy15.05.03.003; 17.05.03.004---
Muscle haemorrhage12.01.07.016; 15.05.03.017; 24.07.01.037---
Muscle spasms15.05.03.004--
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